75N91020R00027_amendment 2.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

N/A

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

November 3, 2020

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Room 1E620, MSC 9705 Bethesda, MD 20892-9705

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

75N91020R00027

9B. DATED (SEE ITEM 11)

September 25, 2020

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offersis extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15 and returning ___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor _ _ is not X is required to sign this document and return 1 _ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to answer questions posed by potential Offerors.

All other terms and conditions of this RFP as amended, including closing date and time, remain unchanged.

Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Paula A. Wilkison

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY _____________________________________

(Signature of Contracting Officer)

16C.DATE SIGNED

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV 10-83.)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

Amendment 2 – RFP 75N91020R00027: Sponsor and Regulatory Oversight Support

1. QUESTION: RFP page 68, Section L.1.d.1: states that the (10 year) award “will be made on/about TBD.”

For proposal purposes, please provide an estimated/assumed start date for the 10-year period of performance.

RESPONSE: For proposal purposes, please use July 1, 2021 as the estimated start date.

2. QUESTION: Attachment 3, SOW page 14, Section 6.1.c states that “The Contractor shall support transition of legacy documents into the electronic Regulatory Management System.”

a. In what electronic Management System, if any, are the legacy documents maintained now?

b. Could the Government provide a list of document types and formats (e.g., Form 1572 PDF) for those legacy documents?

c. Specifically, what information may be provided to support automation for the required transition?

RESPONSE:

a. The legacy documents are present in a combination of electronic files without metadata

(shared drives), SharePoint environment and Medidata Electronic Trial Masterfiles (eTMF) and Electronic Standard Operating Procedure (eSOP) environment. A specific document type could be present in each of those environments.

b. Assume that all documents that included in a TMF and all documents requires for electronic submissions to the FDA will be included in the legacy documents that would require transition.

c. Assume that automation will be minimal. The file structures of the legacy environments would be provided. Assume that for all files not captured in the eTMF/eSOP there will be no consistent metadata available.

3. QUESTION: Attachment 3, Statement of Work, page 18, states: “The Contract includes Options to provide for an increase in Level-of-Effort (10,400 additional hours) in two increments to a maximum of 20,800 hours per year to address unanticipated NCI clinical trial support needs to accommodate projects that may be required in response to emerging needs or public health emergencies.

i. Option A: Increase to Level-of-Effort by 10,040 hours

ii. Option B: Increase to Level-of-Effort by 10,040 hours.

(The Option for 10,400 hours may be exercised up to two times per Contract year.)”

We believe the intent is that Option A and Option B will increase Level of Effort by 10,400 hours each (and not 10,040 hours as stated above in i. and ii); please confirm.

RESPONSE: Option A and Option B, if funded and exercised, increase Level of Effort by 10,400 hours each; it is possible that both Option A and Option B will be both be exercised in any given year of performance, for a total additional 20,800 hours in that given year of performance.

4. QUESTION: Attachment 7, Additional technical proposal document. Page 2-3, Technical Approach, b Quality Management System. #2 Electronic Quality Management System (eQMS).

Is the intent to create one platform with the eQMS, regulatory submission system, eTMF, and PVG system speaking to one another/sharing data?

RESPONSE: NCI’S goal is to have a system that will provide seamless operations for the user between the systems identified in the question. The choice of whether to use a single system, multiple systems that interchange data, or any other technical solution is up to the offeror.

5. QUESTION: Attachment 12, Additional Business Proposal Instructions – Item B.4

(attachment pg. 3): Support of Clinical Studies, states that “1) Assume 4 appropriate experts to be identified and hired as consultants for the duration of 6 months…”

Should offerors budget for the 4 experts, at half-time effort (e.g. 940 hours per year), or would they be on an “as needed” basis (thus not budgeted explicitly)?

RESPONSE: For purposes of budgeting only assume that 4 experts at half-time effort would be utilized. Once the contract is awarded the actual utilization of the experts will be on “as needed” basis.

6. QUESTION: Attachment 12, Additional Business Proposal Instructions – Item C (attachment

pg. 3): Sample Cost Breakdown for Hypothetical Clinical Trial does not provide the Period of performance/start date.

For proposal purposes, what start date should be used for the Hypothetical Clinical Trial and what is the period of performance?

RESPONSE: Assume the start date is July 1, 2021. Refer to assumptions 5 and 6 as for the period of performance.

7. QUESTION: Attachment 12, section B.1.1): Could you please confirm if all the visit numbers listed are for each contract year?

RESPONSE: As stated in B.1.1. the assumptions provided are for each year of the contract performance period.

8. QUESTION: Attachment 12, section B.1.1): Two sets of 3-day IMVs are mentioned: 150 3-day IMVs related to the 60 new protocols and 450 3-day IMVs related to the 145 active protocols. Are the 150 visits included or in addition to the 450?

RESPONSE: The number of IMV required are cumulative throughout the performance period of this contract. For already ongoing studies there will be a total of 450 3-day IMV. In each year of the contract there would be 60 new protocols that would require 150 3-day IMV.

However, those numbers reflect the IMV required per study, not the number required per year of performance.

ADDITIONAL ASSUMPTIONS:

a. The enrollment period remaining for each on-going study is 2 years.

b. The follow-up period for each participant in all studies is 3 years.

Use the above assumptions to distribute the IMV over the expected time period.

9. QUESTION: Attachment 12, section B.1.1): Two sets of COVs are mentioned: 75 COVs related to the 60 new protocols and 100 COVs related to the 145 active protocols. Are the 70 visits included or in addition to the 100?

RESPONSE: The number of COV required are cumulative throughout the performance period of this contract. For already ongoing studies there will be a total of 100 COV. In each year of the contract there would be 60 new protocols that would require 75 COV. However, those numbers reflect the COV required per study, not the number required per year of performance.

Use the above assumptions to distribute the COV over the expected time period.

10. QUESTION: The RFP specifies that a single Principal Investigator/Project Director be identified - please clarify if this refers to a single person, or to two people (a Principal Investigator and a separate Project Director).

RESPONSE: NCI will accept either option. The offeror should describe the line of authority, responsibilities, and communications if more than one person will be designated for the dual role.

11. QUESTION: On page 128 of the RFP, (Attachment 3, Statement of Work, Section 9 Specialized Expertise), ten areas of specialized expertise are listed. Please clarify if the offeror is required to address their expertise in all of those areas in their response.

RESPONSE: The offeror should address how they would tap to all of the identified categories. It is acceptable if the offeror does not have in-house expertise in all of those categories; however, it is expected that the offeror will have access to experts in all those categories.

13. QUESTION: On page 175 of the RFP, B.4.1 Specialized Expertise, 4 appropriate experts are to be hired as consultants in the designated specialized areas. Are these the only 4 areas where the offeror is expected to provide expertise? If the offeror has staff with the expertise requested, can they be used as part of the FTE allocation for the contract, instead of hiring consultants?

RESPONSE: The business assumptions provided in section B.4.1. are for budgeting purposes only. If the offeror has the expertise in-house, they could be used as part of the FTE allocation.

The SOW, Section 9, lists the categories of experts expected under this contract and it is not limited for the 4 expert that are identified on B.4.1.

14. QUESTION: On page 109 of the RFP, sample task orders are referenced as part of the page limit. We did not identify any sample task orders that are required as part of this proposal, please clarify what this point refers to, if any, for this RFP.

RESPONSE: There is no sample task order associated with this RFP; please disregard the mention of it. This is merely RFP “boiler plate” language listing items that could potentially impact page limits.

15. QUESTION: Multiple places in the RFP mention international regulations/clinical trial and product registration, international equivalent regulatory submissions, and supporting international sites. Can NCI/CCR please specify the current number of studies in its portfolio that include international sites and provide the specific list of countries?

RESPONSE: Currently there are no international sites in the portfolio. There are no concrete plans to open sites in international sites; however, the contract is expected to provide expertise in international regulations and support international sites in the event such a case would arise.

16. QUESTION: Within the Additional Business Proposal Instructions, there are no assumptions around the support of international studies, sites, countries, etc. Can the Government please provide an annual order of magnitude estimate for international support over the 10-year period of performance?

For example, of the 10 new studies per year that will be conducted at an average of 5 domestic sites (outside of the NIH Clinical Center), can we assume a certain number of those studies will involve international support? Will any of the studies conducted at the NIH Clinical Center involve international support or subjects from ex-US locations?

RESPONSE: For budgeting purposes assume that there are no international sites involved, and no international support will be needed.